Safety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks

• Status: Completed
• Trial end date: 1989-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the interaction of probenecid with zidovudine (AZT). Because AZT is eliminated quickly from the body, it must be taken frequently. A previous study showed that probenecid slowed the elimination of AZT without side effects, but that study lasted only 5 days. This study is to see whether this effect continues for 1 month and whether the continuation of probenecid and AZT is free of side effects over 1 month.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Probenecid; Zidovudine

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Interferon.

• Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.

Concurrent Treatment:

Allowed:

• Radiation for skin lesions.

Patients with symptomatic HIV infection taking zidovudine (AZT) five or six times a day as therapy. Includes patients with AIDS who have history of cytologically confirmed Pneumocystis carinii pneumonia (PCP), patients with advanced AIDS related complex (ARC), and HIV antibody positive patients.

Patients must be able to give written informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

• Allergy to probenecid.

• Any underlying medical condition sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy.

• History of urinary tract urate stones or gout.

• Becoming acutely ill, unstable, or febrile.

Concurrent Medication:

Excluded:

• Methotrexate.

• Antiretroviral drugs.

• Ganciclovir.

• Amphotericin.

• Experimental drugs.

• Isoniazid.

• Pyrazinamide.

• Flucytosine.

• Intravenous pentamidine.

• Dapsone.

• Fansidar.

• Antineoplastic drugs not specifically allowed.

• Trimethoprim / sulfamethoxazole.

• Valproic acid.

• Opiates.

• Rifampin.

• Sulfonylureas.

Concurrent Treatment:

Excluded:

• Radiation not specifically allowed.

Patients with the following are excluded:

• Allergy to probenecid.

• Any underlying medical condition sufficient, in investigator's opinion, to prevent adequate compliance with study therapy.

• History of urinary tract urate stones or gout.

• Becoming acutely ill, unstable, or febrile.